Colorectal CancerCLARITYNCT07903571
Cohort Study to eLucidAte Causes, Behaviour and Outcomes of gastRo Intestinal Tract Cancers in the Young
An observational study of Colorectal Cancer and Gastro-oesophageal Adenocarcinoma, run by Royal Marsden NHS Foundation Trust.
Trial summary
This study aims to better understand how gastrointestinal (digestive system) cancers develop and how they respond to treatment in young adults, in order to improve ways to prevent, diagnose, and manage these cancers in this age group. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Colorectal Cancer, Gastro-oesophageal Adenocarcinoma, Hepato-Biliary Carcinoma in Situ Nos
- What is being tested?
- Research blood samples
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Nov 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients must be receiving treatment at The Royal Marsden NHS Foundation Trust.
Who may be able to join
- -Cohort A: Colorectal Cancer including at least 20 patients with appendiceal cancer.
- Cohort B: Gastro-oesophageal cancer
- Cohort C: Hepato-biliary cancer
- Patient is 18-50 years of age 3 Patient can understand the patient information sheet and is able to provide written informed consent.
- 4. Patient being treated at the Royal Marsden Hospital.
Who cannot join
- Patients who have received prior treatment for their gastrointestinal malignancy (includes any systemic anti-cancer therapy, radiotherapy and / or surgical resection.
- Patients with a cancer of pancreatic origin (existing institutional biobank), or hepatocellular carcinoma (HCC)
- Patients with a history another of malignancy with within 2 years, excluding resected non melanomatous skin cancers.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
GI Trials GI Trials contact
About this study
Official title: A Prospective Translational Tissue Collection Study in Gastrointestinal Cancers in Young Adults.
This study aims to better understand how gastrointestinal (digestive system) cancers develop and how they respond to treatment in young adults, in order to improve ways to prevent, diagnose, and manage these cancers in this age group.
Read the detailed description
This prospective study is designed to establish a database of young adult patients diagnosed with gastro-intestinal malignancies, with availability of matched clinical data and biological samples including but not limited to tumour tissue. This will serve as a valuable platform to sub studies and collaboration with national and international groups, to better understand the pathogenesis of cancers in this unique cohort and to better tailor treatment to maximise efficacy and minimise toxicity. The analysis plan will develop as the study progresses. At the outset, three areas of interest for investigation are molecular profiling of the tumour and it's microenvironment, the intestinal microbiome and collaboration with groups developing patient derived organoids and metabolomics. It may also provide a platform for future longitudinal research to identify long term health trends.
- Conditions
- Colorectal Cancer, Gastro-oesophageal Adenocarcinoma, Hepato-Biliary Carcinoma in Situ Nos
- Being tested
- Research blood samples
- Keywords
- prospective, translational, tissue collection, gastro-intestinal cancers, young adults
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research blood samplesBiological
Sample taken at baseline, 8-12 weeks post first treatment commencement and at first disease progression or relapse.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Patients aged under 50 with colorectal cancer (including at least 20 patients with appendiceal cancer) Receives: Biological: Research blood samples | |
| Cohort B | Patients aged 18-50 with gastro-oesophageal cancer Receives: Biological: Research blood samples | |
| Cohort C | Patients aged 18-50 with Hepato-biliary cancer. Receives: Biological: Research blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of a prospective early-onset gastrointestinal cancer cohort and biorepositor
Number of participants recruited to the cohort with linked biospecimen collection, clinical data capture, and longitudinal follow-up completed according to protocol.
Measured: 5 years
Secondary outcomes (3)
Lifestyle, dietary, environmental, and early-life exposures
Characterisation of lifestyle, dietary, environmental, and early-life factors and their association with cancer subtype, molecular characteristics, disease stage, and clinical outcomes.
Measured: Baseline and up to 5 years follow-up
Gut microbiome characteristics
Association between gut microbiome composition and tumour characteristics, treatment response, disease progression, and survival outcomes.
Measured: Baseline and up to 5 years follow-up
Circulating biomarkers and translational research markers
Changes in patient-reported quality of life following diagnosis and treatment of early-onset gastrointestinal cancer, as measured using validated questionnaires.
Measured: Baseline and up to 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2031 (estimated)
- Study completion1 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Professor Naureen Starling, FRCP, MD. MRCP, MBBS, BSc Hons, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903571
- Sponsor's protocol ID
- IRAS ID 351293
- Acronym
- CLARITY
- Status last verified
- Oct 2026
- First submitted
- 2 Jan 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided at present
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Translational Tissue Collection Study in Gastrointestinal Cancers in Young Adults.
- ClinicalTrials.gov ID
- NCT07903571
- Acronym / sponsor ID
- CLARITY / IRAS ID 351293
- Conditions
- Colorectal Cancer, Gastro-oesophageal Adenocarcinoma, Hepato-Biliary Carcinoma in Situ Nos
- Keywords
- prospective, translational, tissue collection, gastro-intestinal cancers, young adults
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2031 (estimated)
- Study completion
- 1 Nov 2032 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to better understand how gastrointestinal (digestive system) cancers develop and how they respond to treatment in young adults, in order to improve ways to prevent, diagnose, and manage these cancers in this age group.
Detailed description
This prospective study is designed to establish a database of young adult patients diagnosed with gastro-intestinal malignancies, with availability of matched clinical data and biological samples including but not limited to tumour tissue. This will serve as a valuable platform to sub studies and collaboration with national and international groups, to better understand the pathogenesis of cancers in this unique cohort and to better tailor treatment to maximise efficacy and minimise toxicity. The analysis plan will develop as the study progresses. At the outset, three areas of interest for investigation are molecular profiling of the tumour and it's microenvironment, the intestinal microbiome and collaboration with groups developing patient derived organoids and metabolomics. It may also provide a platform for future longitudinal research to identify long term health trends.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Biological: Research blood samplesPatients aged under 50 with colorectal cancer (including at least 20 patients with appendiceal cancer) |
| Cohort B | – | Biological: Research blood samplesPatients aged 18-50 with gastro-oesophageal cancer |
| Cohort C | – | Biological: Research blood samplesPatients aged 18-50 with Hepato-biliary cancer. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients must be receiving treatment at The Royal Marsden NHS Foundation Trust.
Key inclusion criteria (5 listed)
- -Cohort A: Colorectal Cancer including at least 20 patients with appendiceal cancer.
- Patient is 18-50 years of age 3 Patient can understand the patient information sheet and is able to provide written informed consent.
- 4. Patient being treated at the Royal Marsden Hospital.
Key exclusion criteria (4 listed)
- Patients who have received prior treatment for their gastrointestinal malignancy (includes any systemic anti-cancer therapy, radiotherapy and / or surgical resection.
- Patients with a cancer of pancreatic origin (existing institutional biobank), or hepatocellular carcinoma (HCC)
- Patients with a history another of malignancy with within 2 years, excluding resected non melanomatous skin cancers.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research blood samplesSample taken at baseline, 8-12 weeks post first treatment commencement and at first disease progression or relapse. | Biological | Cohort A, Cohort B, Cohort C |
Primary outcome
Establishment of a prospective early-onset gastrointestinal cancer cohort and biorepositor
Time frame: 5 years
Number of participants recruited to the cohort with linked biospecimen collection, clinical data capture, and longitudinal follow-up completed according to protocol.
3 secondary outcomes
Lifestyle, dietary, environmental, and early-life exposures
Time frame: Baseline and up to 5 years follow-up
Gut microbiome characteristics
Time frame: Baseline and up to 5 years follow-up
Circulating biomarkers and translational research markers
Time frame: Baseline and up to 5 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided. Undecided at present
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GI Trials GI Trials contact
Professor Naureen Starling, FRCP, MD. MRCP, MBBS, BSc Hons principal investigator
Royal Marsden NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Gastro-oesophageal Adenocarcinoma, run by Royal Marsden NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire M Saffery (+44208 915 4480, claire.saffery@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of a prospective early-onset gastrointestinal cancer cohort and biorepositor (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.